Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

NCT05266586 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: TA-8995-202
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 16

Brief Summary

This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.

Conditions

Dyslipidemias; High Cholesterol; Hypercholesterolemia

Keywords

obicetrapib; statin; LDL-C; cholesterol; atherosclerosis

Outcome Measures

Primary Outcomes (6)

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

  Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

  12-weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

  Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

  12-Weeks

• LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

  LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).

  12-Weeks

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

  Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  12-Weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

  Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  12-Weeks

• LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

  LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  12-Weeks

Secondary Outcomes (12)

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

  12-weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

  12-Weeks

• LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]

  12-Weeks

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]

  12-Weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]

  12-Weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

once-daily placebo tablet and placebo capsule

Other: Obicetrapib placebo; Other: Ezetimibe placebo

monotherapy

EXPERIMENTAL

once-daily obicetrapib 10 mg tablet and placebo capsule

Drug: Obicetrapib; Other: Ezetimibe placebo

combination therapy

EXPERIMENTAL

once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule

Drug: Obicetrapib; Drug: Ezetimibe 10mg

Interventions

Obicetrapib DRUG

tablets

Also known as: CETP inhibitor

combination therapy; monotherapy

Ezetimibe 10mg DRUG

capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.

combination therapy

Obicetrapib placebo OTHER

tablets; no active ingredient

Placebo

Ezetimibe placebo OTHER

capsules; no active ingredient

Placebo; monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL-C \> 70 mg/dL and Triglycerides \< 400 mg/dL,
• Treated with a high-intensity statin therapy

You may not qualify if:

• BMI \>= 40 kg/m2
• Significant cardiovascular disease
• HbA1c \>= 10%
• Uncontrolled hypertension
• Active muscle disease
• estimated glomerular filtration rate \< 60 mL/min
• Hepatic dysfunction
• History of participation in any clinical trial evaluating obicetrapib
• Anemia
• History of malignancy
• Alcohol abuse
• Treatment with investigational product
• Treatment with PCSK9
• Clinically significant condition
• Known CETP inhibitor allergy

Sponsors & Collaborators

• NewAmsterdam Pharma: lead

Study Sites (16)

Velocity Clinical Research - Westlake d.b.a National Research Institute

Los Angeles, California, 90057, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

Ocala Cardiovascular Research

Ocala, Florida, 34471, United States

Location

A & R Research Group, LLC

Pembroke Pines, Florida, 33024, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Meridian Clinical Research - Savannah, GA

Savannah, Georgia, 31406, United States

Location

Velocity Clinical Research

Meridian, Idaho, 83642, United States

Location

Biofortis, Inc

Addison, Illinois, 60101, United States

Location

Northwest Heart Clinical Research, LLC

Arlington Heights, Illinois, 60005, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Research Integrity LLC

Owensboro, Kentucky, 42303, United States

Location

Oakland Medical Research Center

Troy, Michigan, 48085, United States

Location

Mercury Street Medical

Butte, Montana, 59701, United States

Location

Meridian Clinical Research- Springdale, OH

Cincinnati, Ohio, 45219, United States

Location

Aventiv Research, Inc.

Columbus, Ohio, 43213, United States

Location

Summit Research Group, LLC

Munroe Falls, Ohio, 44240, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia; Atherosclerosis

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: NewAmsterdam Pharma

study.director@newamsterdampharma.com

+1(305) 627-3081

Study Officials

• Marc Ditmarsch

  NewAmsterdam Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo tablet made to resemble active; placebo capsule made to resemble active
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, double-blind, randomized

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: March 9, 2022
• Primary Completion: August 12, 2022
• Study Completion: September 8, 2022
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)